Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200655
Status:
COMPLETED
Last Update Posted:
2016-04-28
First Post:
2005-09-12
Brief Title:
Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple Sclerosis
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Safety and Efficacy of Pravastatin in Relapsing-remitting MS a Double Blind Placebo Controlled Study
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Therapeutic strategies for multiple sclerosis MS are essentially based on the use of immunomodulatory agents such as interferon b and glatirmere acetate but their efficacy is quite limited they are not well tolerated and they have a very high cost Recent works showed an immunomodulatory effects of HMG-CoA reductase inhibitors the so-called statins In experimental allergic encephalopathy a murine model of MS statins inhibit the onset and progression of the disease through a shift from Th1 towards Th2 cytokine production Other in vitro studies suggest the ability of statins to inhibit the lymphocyte migration through the blood brain barrier Furthermore in an open labeled human study in MS statin regimen was associated with a decreased lesional activity assessed by MRI Statins are well tolerated drugs used for many years with a low cost and with a putative efficacy in MS The investigators suggest to test the pravastatin safety and efficacy on MRI criteria in a double-blind placebo-controlled study in 40 patients with a relapsing-remitting MS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None